Thursday, April 17, 2003
The FDA letter doesn't say why the hospital's statements were misleading.
PITTSBURGH (AP) -- Claims by the Food and Drug Administration that a Pittsburgh hospital misled the public about a fatal bacterial outbreak are the result of a misunderstanding, hospital officials said.
Dr. Richard Shannon, Allegheny General Hospital chairman, and vice president Tom Chakurda said the hospital mistakenly identified an equipment recall as ordered by the FDA. The company that manufactured the equipment issued the recall, and the FDA published information about the recall, Chakurda said.
"This is a matter of putting this in perspective. With headlines accusing us of a cover-up, when we have been forthcoming since the beginning, is incredible to us," Chakurda said Saturday, a day after the claims were made public.
FDA letter
The FDA released a letter last week in which it told hospital officials they misled the public by referring publicly to FDA recalls of a device used to clean bronchoscopes, small flexible tubes used to look inside the lungs of critically ill patients, and take biopsy sections.
The letter, written by Timothy Ulatowski of the FDA's Center for Device and Radiological Health, said hospital statements "regarding the FDA recalls misrepresented the facts of the situation and were considered to be false and misleading to the public."
Hospital officials said an internal investigation has determined the instruments were dirty because of problems with a machine used to clean them.
Sterilizing device
Bronchoscopes exposed 16 patients to bacteria last year, including one man whose death was linked directly to the Pseudomonas bacteria, which is common but can cause pneumonia in severely ill people.
Hospital officials have said since the October incidents that a part of the sterilizing device had been recalled in May 2002, but that the manufacturer didn't properly advise the hospital of safety risks.
The device, manufactured by Steris Corp. of Mentor, Ohio, is used by thousands of U.S. hospitals to clean bronchoscopes and other medical equipment.
The FDA letter doesn't specifically say why the hospital's statements were misleading. It summarized a March 10 conference call during which hospital officials spoke with FDA officials about the bacteria.
The letter said that hospital officials discussed the possibility that employees misused the sterilizing machine. Hospital officials have repeatedly said they ruled out employee errors.
An FDA spokeswoman declined to comment. Steris officials wouldn't address the hospital's allegations, but defended their machine.